🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Spain / NCT05309707
Recruiting Observational

ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"

NCT05309707 · tracked via the Priya Life Science Spain tracker
Sponsor
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Phase
Observational
Started
2022-01-01
Last updated
2022-04-04

Condition(s) studied

Thoracic Aortic AneurysmThoracic Aortic DissectionStent-Graft EndoleakStent-Graft StenosisIntramural HematomaAortic DiseasesCardiovascular DiseasesVascular Diseases

Investigational drug(s) / intervention(s)

Endovascular exclusion

Endovascular exclusion: Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

Study summary

The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

The secondary objective is to evaluate the safety and clinical performance of the studied devices.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Patient is between 18 and 90 years old * Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0. * Patient must be available for the appropriate follow-up times for the duration of the study * Informed consent signed. Exclusion Criteria: * Patient less than 18 years old or more than 90 years old. * Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium) * Patient has systemic infection or suspected systemic infection * Patient has thrombocytopenia (platelet count \< 150000/µl) * Patient has untreated hyperthyroidism * Patient has a progressive or untreated malignancy. * Patient is pregnant or breastfeeding. * Patient has a life expectancy of less than 1 year. * Not informed consent signed

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Spanish society for Angiology and Vascular Surgery Madrid Spain Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05309707 on ClinicalTrials.gov ↗ ← All trials in Spain